MOLOGEN AG: Results of the extension phase of the exploratory phase Ib/IIa study in HIV

The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) presents key results of the extension phase of the exploratory phase Ib/IIa TEACH trial, a cooperation with the Aarhus University Hospital in Denmark.

The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) presents key results of the extension phase of the exploratory phase Ib/IIa TEACH trial, a cooperation with the Aarhus University Hospital in Denmark. The study was designed to evaluate the Company’s lead product, the immunotherapeutic agent lefitolimod, in HIV-positive patients on antiretroviral therapy (ART). The main study results are as follows:• Sustained increases in activation of important immune cells (CD4 and CD8 T cells) were observed throughout the dosing period of 24 weeks.• Lefitolimod triggered maturation of other important immune cells (B cells) towards antibody-producing cells. • After interruption of ART, one of the nine patients who participated in that study part showed viral control for more than 20 weeks, whereas the interval until viral rebound is generally two weeks.• The intervention had no detectable effects on the size of viral reservoir in peripheral blood in the total study population of 12 patients, which was defined as the primary endpoint of the extension phase of the study.• 24 weeks of lefitolimod treatment was safe and well tolerated in HIV patients on ART, corroborating the favourable safety profile already seen in cancer patients.In summary these data suggest – although lefitolimod alone on top of ART did not show the desired effect on the viral reservoir - lefitolimod could be an important combination partner for other interventions aiming at HIV cure, such as monoclonal antibodies or vaccines.A more extensive evaluation of the TEACH data is currently ongoing including further immune and HIV reservoir parameters.

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